SIST EN ISO 18778:2009

Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)

This International Standard specifies requirements for the safety and essential performance of monitors used
to detect apparent life-threatening events1) in sleeping or resting children under three years of age. This
International Standard applies to devices used in home care applications. These monitors are generally used
without continual professional supervision.
This International Standard also applies to the accessories, e.g. probes and cables necessary to apply the
monitor to the patient.
This International Standard does not apply to monitors intended for use in health care facilities/institutions.
The requirements of this International Standard, which replace or modify the requirements of
IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over the
corresponding general requirements.

Beatmungsgeräte - Überwachungsgeräte für Kleinkinder - Besondere Anforderungen (ISO 18778:2005)

IEC 60601-1:1988, Abschnitt 1, gilt mit folgenden Ausnahmen:
Änderungen (am Ende von 1.1 ergänzen):
1.1
Diese Internationale Norm legt Anforderungen für die Sicherheit und die wesentlichen Leistungsmerkmale von
Überwachungsgeräten fest, die zur Erkennung offenbar lebensbedrohlicher Ereignisse bei schlafenden oder
ruhenden Kindern unter drei Jahren verwendet werden1). Diese Internationale Norm gilt für Geräte, die bei
der häuslichen Pflege angewendet werden. Diese Überwachungsgeräte werden im Allgemeinen ohne
ständige Überwachung durch Fachpersonal verwendet.
Diese Internationale Norm gilt auch für die Zusatzteile, z. B. Tastköpfe und Kabel, die zur Anlegung des
Überwachungsgeräts am Patienten erforderlich sind.
Diese Internationale Norm gilt nicht für Überwachungsgeräte, die für die Verwendung in Einrichtungen des
Gesundheitswesens vorgesehen sind.
Die Anforderungen dieser Internationalen Norm, die die Anforderungen von IEC 60601-1:1988 mit ihren
Änderungen 1 (1991) und 2 (1995) ersetzen oder ändern, haben Vorrang gegenüber den entsprechenden
allgemeinen Anforderungen.
1.4
Ergänzung:
ANMERKUNG Die Planung und Gestaltung von Produkten, die dieser Norm entsprechen, können im Lebensablauf des
Produkts Auswirkungen auf die Umwelt haben. Umweltgesichtspunkte werden in Anhang BB behandelt. Zusätzliche
Gesichtspunkte der Umweltauswirkungen werden in ISO 14971 behandelt.

Matériel respiratoire - Moniteurs pour enfants - Exigences particulières (ISO 18778:2005)

L'ISO 18778:2005 spécifie les prescriptions essentielles de sécurité et de performance applicables aux moniteurs utilisés pour détecter des situations constituant un risque vital pour les enfants âgés de moins de trois ans. La présente Norme internationale s'applique aux dispositifs utilisés dans des applications de soins à domicile, généralement sans surveillance continue d'un professionnel.
L'ISO 18778:2005 s'applique également aux accessoires tels que les sondes et les câbles nécessaires pour placer le moniteur sur le patient. Elle ne s'applique pas aux moniteurs destinés à être utilisés dans des installations/établissements de soins.

Respiratorna oprema - Monitorji za otroke - Posebne zahteve (ISO 18778:2005)

General Information

• Status: Withdrawn
• Publication Date: 31-May-2009
• Withdrawal Date: 07-Dec-2022
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Dec-2022
• Due Date: 24-Dec-2022
• Completion Date: 08-Dec-2022
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 18778:2009 - Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)

Relations

• Replaces: SIST EN ISO 18778:2005 - Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
• Effective Date: 01-Jul-2009
• Replaced By: SIST EN ISO 18778:2023 - Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022)
• Effective Date: 01-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 18778:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 18778:2005
Respiratorna oprema - Monitorji za otroke - Posebne zahteve (ISO 18778:2005)
Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
Beatmungsgeräte - Überwachungsgeräte für Kleinkinder - Besondere Anforderungen
(ISO 18778:2005)
Matériel respiratoire - Moniteurs pour enfants - Exigences particulières (ISO 18778:2005)
Ta slovenski standard je istoveten z: EN ISO 18778:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 18778:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 18778:2009

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SIST EN ISO 18778:2009
EUROPEAN STANDARD
EN ISO 18778
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 18778:2005
English Version
Respiratory equipment - Infant monitors - Particular
requirements (ISO 18778:2005)
Matériel respiratoire - Moniteurs pour enfants - Exigences Beatmungsgeräte - Überwachungsgeräte für Kleinkinder -
particulières (ISO 18778:2005) Besondere Anforderungen (ISO 18778:2005)
This European Standard was approved by CEN on 21 March 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18778:2009: E
worldwide for CEN national Members.

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SIST EN ISO 18778:2009
EN ISO 18778:2009 (E)
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 18778:2009
EN ISO 18778:2009 (E)
Foreword
The text of ISO 18778:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 18778:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the
secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 18778:2005.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 18778:2005 has been approved by CEN as a EN IS
...